FDA Inspection
Karex Industries Sdn BhdKarex Industries Sdn Bhd – FDA Inspection, Oct 18, 2018
Record Details
This FDA Inspection record concerns Karex Industries Sdn Bhd, with an inspection on October 18, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Karex Industries Sdn Bhd
- Inspection Date
- October 18, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · c7ef764f-3cbe-4ac3-90d0-178f665fe220
Inspection Facts
- Inspection number
- 1074703
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Karex Industries Sdn Bhd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Karex Industries Sdn Bhd
- FDA Inspection 782301 - 2012-04-19
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